MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 6-0 BLU; SUTURES - NON-ABSORBABLE

Model Number	EP8806H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.It was received for analysis empty opened labeled winding former of product code ep8806h, lot pdr735.As no suture was returned for evaluation, we are unable to investigate further to the issue.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke very easily.There were no adverse patient consequences.

• Brand Name: PROLENE SUTURE 18"(45CM) 6-0 BLU
• Common Device Name: SUTURES - NON-ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10287423
• Report Number: 2210968-2020-05365
• Device Sequence Number: 3294158
• Product Code: GAW
• UDI-Device Identifier: 10705031208254
• UDI-Public: 10705031208254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: EP8806H
• Device Catalogue Number: EP8806H
• Device Lot Number: PDR735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/17/2020
• Patient Sequence Number: 1